scholarly journals Meta-analyses of adjuvant therapies for women with early breast cancer: the Early Breast Cancer Trialists’ Collaborative Group overview

2006 ◽  
Vol 17 ◽  
pp. x59-x62 ◽  
Author(s):  
M. Clarke
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Collaborative Group ◽  
Adjuvant Therapies ◽  
Meta Analyses

Inferring the Effects of Cancer Treatment: Divergent Results From Early Breast Cancer Trialists’ Collaborative Group Meta-Analyses of Randomized Trials and Observational Data From SEER Registries

2016 ◽  
Vol 34 (8) ◽  
pp. 803-809 ◽  
Author(s):  
Katherine E. Henson ◽  
Reshma Jagsi ◽  
David Cutter ◽  
Paul McGale ◽  
Carolyn Taylor ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Observational Data ◽  
Early Breast Cancer ◽  
Rate Ratio ◽  
Randomized Trials ◽  
Breast Conserving Surgery ◽  
Collaborative Group ◽  
Node Positive Disease ◽  
Rate Ratios ◽  
Meta Analyses

Purpose To compare the effect of breast cancer radiotherapy as estimated from observational data with findings from randomized trials. Materials and Methods Rate ratios were obtained for selected end points among 13,932 women randomly assigned to receive radiotherapy or not in trials contributing to recent meta-analyses by the Early Breast Cancer Trialists’ Collaborative Group. Estimates of the same quantities were derived for 393,840 women registered with breast cancer in the US SEER registries between 1973 and 2008. Results In the randomized trials, radiotherapy after breast-conserving surgery reduced mortality from both breast cancer (rate ratio, 0.82; 95% CI, 0.75 to 0.90) and all causes (rate ratio, 0.92; 95% CI, 0.86 to 0.99). Reductions of similar magnitude were seen in the trials of radiotherapy after mastectomy in node-positive disease (rate ratios, breast cancer 0.84; 95% CI, 0.76 to 0.94; all causes, 0.89; 95% CI, 0.81 to 0.97). In the observational data, radiotherapy after breast-conserving surgery was associated with much larger mortality reductions (rate ratios, breast cancer, 0.64; 95% CI, 0.62 to 0.66; all causes, 0.63; 95% CI, 0.62 to 0.65), whereas radiotherapy after mastectomy in node-positive disease was associated with substantial increases in mortality (rate ratios, breast cancer, 1.34; 95% CI, 1.31 to 1.37; all causes, 1.23; 95% CI, 1.22 to 1.25). Detailed adjustment of the observational data for potential confounders did not reduce the divergence from the randomized data. Conclusion This study of mortality after radiotherapy for breast cancer found strikingly divergent results between the Early Breast Cancer Trialists’ Collaborative Group meta-analyses of randomized data and the SEER observational data, even when efforts had been made to remove confounding and selection biases. Nonrandomized comparisons are liable to provide misleading estimates of treatment effects. Therefore, they need careful justification every time they are used.

scholarly journals Assessing the Clinical Benefit of Systemic Adjuvant Therapies for Early Breast Cancer

2017 ◽  
Vol 77 (10) ◽  
pp. 1079-1087 ◽  
Author(s):  
Volker Möbus ◽  
Susanne Hell ◽  
Marcus Schmidt
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Clinical Benefit ◽  
Early Stage ◽  
Survival Rates ◽  
Disease Free Survival ◽  
New Drugs ◽  
Early Stage Breast Cancer ◽  
Risk Of Recurrence ◽  
Adjuvant Therapies

AbstractOncologic therapy is currently undergoing significant changes. A number of innovative targeted medications currently in clinical development have raised high expectations. With that in mind, discussions about terms such as “clinical benefit” and “clinical relevance” are highly topical. This also applies to further developments in the field of adjuvant systemic therapies for early-stage breast cancer. As the treatment aim is curative, assessment of the clinical benefit of adjuvant therapies must be largely based on efficacy outcomes. The focus must be on improving disease-free survival rates and lowering the risk of recurrence. Because of the current low mortality rates, statements about overall survival rates are only possible after very long observation periods. Consequently, new drugs in adjuvant therapies should be considered as offering a clinical benefit, if they reduce the risk of recurrence below current low levels of risk. The evidence for established adjuvant therapy standards in early-stage breast cancer can be used as objective criteria for comparison. This review article considers the requirements for clinical benefit of new adjuvant therapies for early breast cancer, based on examples from adjuvant endocrine therapy, adjuvant polychemotherapy and adjuvant anti-HER2 therapy.

scholarly journals Application of the ESMO-Magnitude of Clinical Benefit Scale (V.1.1) to the field of early breast cancer therapies

ESMO Open ◽  
2020 ◽  
Vol 5 (5) ◽  
pp. e000743 ◽  
Author(s):  
Shani Paluch-Shimon ◽  
Nathan I Cherny ◽  
Elisabeth G E de Vries ◽  
Urania Dafni ◽  
Martine J Piccart ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Clinical Benefit ◽  
Large Scale ◽  
Disease Free Survival ◽  
Cancer Therapies ◽  
Data Set ◽  
Clinical Scenarios ◽  
Meta Analyses

Click here to listen to the PodcastBackgroundThe European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated value scale for solid tumour anticancer treatments. Form 1 of the ESMO-MCBS, used to grade therapies with curative intent including adjuvant therapies, has only been evaluated for a limited number of studies. This is the first large-scale field testing in early breast cancer to assess the applicability of the scale to this data set and the reasonableness of derived scores and to identify any shortcomings to be addressed in future modifications of the scale.MethodRepresentative key studies and meta-analyses of the major modalities of adjuvant systemic therapy of breast cancer were identified for each of the major clinical scenarios (HER2-positive, HER2-negative, endocrine-responsive) and were graded with form 1 of the ESMO-MCBS. These generated scores were reviewed by a panel of experts for reasonableness. Shortcomings and issues related to the application of the scale and interpretation of results were identified and critically evaluated.ResultsSixty-five studies were eligible for evaluation: 59 individual studies and 6 meta-analyses. These studies incorporated 101 therapeutic comparisons, 61 of which were scorable. Review of the generated scores indicated that, with few exceptions, they generally reflected contemporary standards of practice. Six shortcomings were identified related to grading based on disease-free survival (DFS), lack of information regarding acute and long-term toxicity and an inability to grade single-arm de-escalation scales.ConclusionsForm 1 of the ESMO-MCBS is a robust tool for the evaluation of the magnitude of benefit studies in early breast cancer. The scale can be further improved by addressing issues related to grading based on DFS, annotating grades with information regarding acute and long-term toxicity and developing an approach to grade single-arm de-escalation studies.

Usage and factors associated with adjuvant bisphosphonate therapy among postmenopausal women diagnosed with early-stage breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12532-e12532
Author(s):  
Veera Durga Sravanthi Panuganty ◽  
Suganija Lakkunarajah ◽  
Sumugan Shanmuganathan ◽  
Morgan Black ◽  
Sharifa Nasreen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Practice ◽  
Adjuvant Chemotherapy ◽  
Postmenopausal Women ◽  
Early Breast Cancer ◽  
Breast Cancer Mortality ◽  
Bisphosphonate Therapy ◽  
Collaborative Group ◽  
Time Interval ◽  
Factors Associated

e12532 Background: Early Breast Cancer Trialist Collaborative Group meta-analysis suggested significant reduction in bone metastasis and breast cancer mortality among post-menopausal women diagnosed with early breast cancer when treated with an adjuvant bisphosphonate. Cancer Care Ontario and American Society of Clinical Oncology clinical practice guideline published in 2017, recommends the use of an adjuvant bisphosphonate in postmenopausal women who are candidates for adjuvant systemic therapy. Our goal was to evaluate trends and factors associated with adjuvant bisphosphonate usage since the guideline’s publication. Methods: This study is a retrospective review of postmenopausal women treated for early breast at the London Regional Cancer Program from 2017-2018. Univariate and a multivariable logistic regression models were used to investigate factors potentially associated with adjuvant bisphosphonate use including age, stage, grade, estrogen receptor, progesterone receptor, HER2 receptor status and previous use of adjuvant chemotherapy. The percentage of patients offered, receiving and declining therapy was also recorded and the time interval from surgery to start of bisphosphonate therapy (< 6 months, 6-12 months or >12 months). Results: We identified 286 postmenopausal breast cancer patients, of whom 75 (28%) received adjuvant bisphosphonate therapy. In our multivariable model, cancer stage [odds ratio (OR) stage II vs. I=2.26, 95% confidence interval (CI) 1.08-4.74) and OR Stage III vs. I=4.94, 95% CI 1.84-13.17] and previous use of adjuvant chemotherapy (OR=2.76, 95%CI 1.37-5.55) were significantly associated with adjuvant bisphosphonate use. Among 133 patients who received adjuvant systemic chemotherapy, 51% were offered adjuvant bisphosphonate and of these 81% patients accepted therapy. Among a total of 75 patients receiving adjuvant bisphosphonate therapy 19% initiated therapy within 6 months of surgery, 48% within 6-12 months of surgery, and 33% after 12 months following surgery. Conclusions: Stage and previous use of chemotherapy were significantly associated with adjuvant bisphosphonate therapy. Our study observes the potential underutilization of adjuvant bisphosphonate therapy and possible need to start treatment earlier in some patients. Further education and awareness of the clinical practice guidelines regarding adjuvant bisphosphonate therapy may be warranted and additional population-based study investigating treatment patterns and real-world effectiveness.

scholarly journals Adjuvant chemotherapy for early female breast cancer: A systematic review of the evidence for the 2014 Cancer Care Ontario systemic therapy guideline

2014 ◽  
Vol 22 ◽  
pp. 82 ◽  
Author(s):  
S. Gandhi ◽  
G.G. Fletcher ◽  
A. Eisen ◽  
M. Mates ◽  
O.C. Freedman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Endocrine Therapy ◽  
Early Breast Cancer ◽  
Systemic Therapy ◽  
Cancer Care ◽  
Cytotoxic Chemotherapy ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Meta Analyses

BackgroundThe Program in Evidence-Based Care (PEBC) of Cancer Care Ontario (CCO) has recently created an evidence-based consensus guideline on the systemic treatment of early breast cancer.  The evidence for this guideline was compiled using a systematic review to answer the question:  “What is the optimal systemic therapy for patients with early-stage, operable breast cancer, when patient and disease factors are considered?”  This question was addressed in three parts: cytotoxic chemotherapy, endocrine treatment, and human epidermal growth factor receptor 2 (HER2) directed therapy.MethodsA systematic review was performed using the MEDLINE and EMBASE databases for the period January 2008 to May 2014.  The SAGE Directory of Cancer Guidelines and websites of major oncology guideline organizations were also searched.  The basic search terms were “breast cancer” and “systemic therapy” (chemotherapy, endocrine therapy, targeted agents, ovarian suppression), and was limited to randomized controlled trials (RCTs), guidelines, systematic reviews, and meta-analyses. ResultsSeveral hundred documents were retrieved that met the inclusion criteria; the Early Breast Cancer Trialists Collaborative Group (EBCTCG) meta-analyses encompassed many of the RCTs found. Several additional studies which met the inclusion criteria were included, as well as other guidelines and systematic reviews.  Chemotherapy was largely reviewed as three classes of agents: anti-metabolite based regimens (e.g., CMF), anthracyclines, and taxane-based regimens. Single-agent chemotherapy in general is not recommended for the adjuvant treatment of breast cancer in any patient population.  Anthracycline and taxane-based polychemotherapy regimens are overall considered superior to earlier generation regimens, with the most significant impact on patient survival outcomes. Various regimens with disparate anthracycline and taxane doses and schedules are options; in general, paclitaxel given every 3 weeks is inferior. Evidence does not support the use of bevacizumab in the adjuvant setting; other systemic therapy agents such as metformin and vaccines remain under investigation. Adjuvant bisphosphonates for menopausal women will be discussed in later work.  ConclusionThe results of this systematic review represent a comprehensive compilation of high-level evidence which was the basis for the 2014 PEBC CCO guideline on systemic therapy for early breast cancer. The use of cytotoxic chemotherapy is presented here; the results addressing endocrine therapy and HER-2 targeted treatment, as well as the final clinical practice recommendations, are published separately in this issue.

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